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Etiology of Febrile Illness in Nepal (DEFINe Study)

RecruitingNAAges 16 Years - anyAllPatan Academy of Health Sciences
NCT07004751 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In the absence of a microbiological lab testing, majority of the cases of febrile illnesses in Nepal are diagnosed on a clinical basis alone. These cases of "undifferentiated febrile illness" are treated empirically with multiple antibiotics without an etiological diagnosis. Unnecessary use of antibiotics can increase the risk of antibiotic resistance and adds unnecessary burden of cost to the patients and their families. This study aims to determine the etiology of infections using additional microbiological techniques in patients admitted to the hospital with acute undifferentiated febrile illness of 3 days to 21 days duration, and assess its impact on use of antimicrobial drugs. In addition to the clinical features, the etiological diagnosis will be confirmed by using additional tests including culture techniques and ELISA based serological tests for 7 additional pathogens which are

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 16 years or older * Documented fever (T ≥100.4F or ≥38C) of 3 days to 21 days duration * No obvious diagnosis found on the basis of clinical, radiological, or initial routine laboratory tests\* * Admitted to the medical unit of hospital * Signed ICF (informed consent form) Exclusion Criteria: * Outpatients * Fever of less than 3 days or more than 21 days duration * Patients being discharged from Emergency Room * Children (younger than 16 years in age)\*\* * Immunocompromised patients * Neutropenia (ANC \<500 per cumm) * Known case of HIV infection * Admission to a hospital for 48-hours or longer within past 30 days
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What it tests

  • Additional laboratory analysis
  • Standard of Care (SOC)
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Where

1 site
Patan Academy of Health Sciences
Lalitpur, Nepal
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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